Clinical Factors Associated With the Development of Severe Sepsis in Patients Being Treated for Acute Myeloid Leukemia (AML)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Acute leukemia is a life threatening illness that strikes people of all ages. In addition to surviving the direct effects of the disease, the treatment of leukemia generally requires chemotherapy which has its own burden. Infection is one of the most common secondary problems faced by these patients. Simple infections are common and easily treated with aggressive antibiotics. However, treated progressive infection leads to loss of vital organ function and is termed severe sepsis. Severe sepsis is associated with increased risk of death and the need for specialized care in the intensive care unit.
Besides the appropriate use of antibiotics, little is known about what clinical and patient factors are associated with the development of severe sepsis. Recent evidence has suggested that certain practices like frequent transfusion of blood products and control of glucose levels effects outcome in critically ill patients. In addition, there have been advances in our knowledge of certain genes that may predispose people to severe infections. It is possible that these factors are important in people who are not yet critically ill, but are at risk for the development of severe sepsis.
This observational study will look at genetic, clinical and therapeutic factors that are associated with the development of severe sepsis. This will help doctors understand what treatments may be helpful in preventing this serious complication.
| Condition |
|---|
|
Sepsis Acute Myeloid Leukemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Clinical Factors Associated With the Development of Severe Sepsis in Patients Being Treated for Acute Myeloid Leukemia |
- determine the true relationship of hyperglycemia to the development of severe sepsis after chemotherapy for AML [ Time Frame: end of study ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
baseline blood sample drawn (2 tablespoons or 30 ml) at the beginning of the study. If subjects experience a fever another blood sample (10 ml up to 2 times) will be drawn at that time.
| Enrollment: | 120 |
| Study Start Date: | November 2007 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
AML
Adult patients with AML admitted for treatment of the same
|
Detailed Description:
Primary hypothesis: Hyperglycemia during inpatient therapy of AML is associated with increased mortality (fewer hospital free days to Day 60, see below).
- H1a: Hyperglycemia will result in an increased risk of developing clinical signs of infection (fever).
H1b: Hyperglycemia will be associated with an increased risk of developing severe sepsis after the onset of clinical signs of infection (fever).
o H1b1: Hyperglycemia will be associated with the development of acute lung injury after the onset of signs of infection (fever).
H1c: Hyperglycemia will be associated with an increased risk of ICU admission.
o H1c1: Hyperglycemia will be associated with an increased risk of ICU admission for severe sepsis.
- H1d: Hyperglycemia will be associated with an increased risk of death in those subjects with severe sepsis (fewer hospital free days to Day 60, see below).
Secondary Aim: To investigate whether TSP-1 is important in modulating the course of sepsis-induced acute lung injury.
Secondary hypothesis: In patients with sepsis, increased levels of functional TSP-1 will be associated with a lower incidence of and a less severe course of lung injury.
- H2a: In human sepsis, increased TSP-1 levels will be associated with a lower incidence of lung-injury.
- H2b: In human sepsis, increased TSP-1 levels will be associated with a less severe course of lung-injury.
- H2c: In human sepsis, patients with the Asn682Ser polymorphism in the TSP-1 gene will be associated with a higher incidence of lung-injury.
- H2d In human sepsis, patients with the Asn682Ser polymorphism in the TSP-1 gene will be associated with a more severe course of lung-injury.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
university hospital intensive care unit
Inclusion criteria:
- Diagnosis of acute myeloid leukemia
- Age ≥ 18 years of age
- Plans to receive chemotherapy as an inpatient and remain inpatient until hematologic recovery as determined by the primary treating physician
Exclusion criteria:
- Subject is unlikely to survive > 3 months with treatment
- Current diagnosis of severe sepsis
- Subject or surrogate is unable to give informed consent
- Subject is incarcerated
- Patient's family, physician, or both not in favor of endotracheal intubation or mechanical ventilation for any length of time or the presence of an advanced directive to withhold the same.
- Subject currently requiring mechanical ventilation
- Subject with current diagnosis of acute lung injury or ARDS (bilateral infiltrates on chest X-ray and PF ratio< 300 with no evidence of left atrial hypertension)
- Subject has received chemotherapy for the treatment of AML > 96 hours ago.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Naeem Ali/Principal Investigator, The Ohio State University |
| ClinicalTrials.gov Identifier: | NCT00806325 History of Changes |
| Other Study ID Numbers: | 2006C0052 |
| Study First Received: | December 9, 2008 |
| Last Updated: | May 26, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ohio State University:
|
Severe Sepsis Acute Myeloid Leukemia Sepsis in patients being treated for Acute Myeloid Leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Sepsis Toxemia Neoplasms by Histologic Type |
Neoplasms Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013